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Coronary Artery DiseaseNCT04011527

The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s

An observational study of Coronary Artery Disease, run by Segeberger Kliniken GmbH at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rotational Atherectomy in Coronary Lesion/s
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
1 siteGermany
Study dates
25 Nov 2002to 31 Dec 2032
How long will I take part?
2 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s

Who may be able to join

  • All patients undergoing a rotational atherectomy of coronary lesion/s

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Germany1 site, 1 recruiting
  • Herzzentrum Segeberger Kliniken GmbH

    Bad Segeberg, 23795

    Gert Richardt, MD, +49 4551 802 4801, gert.richardt@segebergerkliniken.de

    Recruiting

Other trials in Germany

About this study

Official title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s

A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s

Read the detailed description

A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Being tested
Rotational Atherectomy in Coronary Lesion/s
Keywords
Calcified coronary artery lesions
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotational Atherectomy in Coronary Lesion/sProcedure or surgery

Study groups in NCT04011527
Study groupRoleWhat they receive
Patients with Coronary Artery DiseasePatients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s
Receives: Procedure: Rotational Atherectomy in Coronary Lesion/s

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of in-hospital and long-term cardiovascular adverse events in percent

    Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start25 Nov 2002
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04011527
Sponsor's protocol ID
SK 111 -- 168/11
Status last verified
Jun 2022
First submitted
28 Jun 2019
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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